SRA Round Table Panel Symposium: Joint Regional Organization Project on Microbiota of Milks

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Title: Deliberating Evidence for Risks and Benefits Posed by Microbiota of Milks

Organizer: Peg Coleman, Upstate NY SRA/Coleman Scientific Consulting (peg@colemanscientific.org)

Moderators: SRA Past-Presidents

Ann Bostrom (abostrom@uw.edu) and

Warner North (northworks@mindspring.com)

Description: Regulators and stakeholders around the world differ in their perceptions of risks and

benefits of fresh unprocessed milks (human and bovine) and pasteurized milks. A joint SRA RO project

began outreach documenting the state of the science on the microbiota of milks and engaging in dialogue

with SRA practitioners and other stakeholders through a webinar series (podcasts, slide sets available).

Two SRA Past-Presidents will moderate discussions of the evidence for risks and benefits of fresh

unprocessed mother’s milk to infants. Evidence of benefits includes multiple clinical studies from

hospitals around the world with preterm neonates in NICU environments. Further, these clinical studies

demonstrate loss of benefits for NICU infants ingesting donor milk that is Holder pasteurized (heated to

62.5°C for 30 minutes). The moderators and panelists will discuss rationales for and against

pasteurization in light of an emerging dimension: the microbiota of milks. Discussions will be grounded

in the major elements of risk communication (trust, fairness, and emotionality). Various risk

communication approaches (evidence mapping, mental modeling) will be considered. Also of keen

interest is evidence for risks and benefits of fresh unprocessed bovine milk for consumers, including

children and adults. Evidence mentioned in the symposium for human milks will be included, along with

additional evidence for bovine milks, in exercises of analytic-deliberative process in the next phase of this

multi-year joint RO project (a 2.5-day stand-alone SRA workshop in 2018). Participants in the symposium

will discuss what is known about the healthy human milk microbiome, research gaps, researchable

questions, and potential improvements in developing evidence-based policies and risk communications.

Panelists include:

Risk communicator Bill Hallman (Rutgers University)

Risk assessors Peg Coleman (Upstate NY SRA) and Tanya Soboleva (Australia/New Zealand SRA)

Microbiome researcher Carmen Tartera (FDA/CFSAN)

Independent scholar Katya Tsaioun (Johns Hopkins University)

Scope and Structure of Round Table Panel Discussions

The symposium is sponsored by the Risk Communication Specialty Group (RCSG). The panel will

consider the scientific evidence in light of the key principles of risk communication:

trust

fairness and

emotionality.

Moderators Ann Bostrom and Warner North both served as past presidents of SRA and offer decades of

expertise in risk communication for controversial issues and analytic deliberative process. They will keep

SRA Round Table Panel Symposium: Joint Regional Organization Project on Microbiota of Milks

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discussion focused on the evidence rather than on positions and perceptions. After an introduction

providing context for the project, the moderators will pose the appended questions to the panel. As time

permits, questions will be posed by the risk practitioners in the SRA audience.

The focus for the round table panel symposium is on evidence for risks and benefits from fresh

unprocessed and pasteurized human milks for infants (NICU and others). Input will be sought on the

state of the evidence and key researchable questions necessary to inform evidence-based decision

making for human donor milk in this phase of the project, and for bovine milk in the next stage of the

project, the 2018 workshop.

Key references are appended from a working draft bibliography prepared for the project (posted on

Upstate NY SRA website at http://sra.org/upstateny), and panelists (and SRA participants) are invited to

offer additional studies before, during, and after the symposium. Some findings from these key studies

will be provided in the symposium slide set.

Studies conducted around the world document increased risks to preterm infants without access to fresh

breast milk for failure to thrive, and morbidity and mortality due primarily to necrotizing enterocolitis

(NEC) and late-onset sepsis (LOS). Limited data exist on protection against severe retinopathy and

bronchopulmonary dysplasia, neurocognitive and cardiovascular damage, and infectious disease agents

including those causing typical foodborne enteric diseases. In many countries, breast milk donors are

routinely screened for infectious diseases by similar methods as for blood donation, and donor milk may

be screened for the presence and levels of indicator bacteria and potential pathogens. The apparent

rationale for pasteurization of donor milks is that pathogens may be present in fresh milks.

Also documented in the published literature are multiple studies demonstrating the presence of up to

700 species of non-pathogenic or commensal bacteria in fresh milks and their functionality for offspring,

particularly immune modulation and establishment of a symbiotic gut microbiota. Clinical trials, many

conducted prior to the advances in the ‘microbiome revolution’ of the recent decade, demonstrate

protective effects of fresh breast milks against many diseases in neonates. Multiple studies demonstrate

dose-dependent protections of breastfed infants and provide explanatory evidence on potential

mechanisms influenced by the milk microbiota. Recent studies considering breast milk culture results

and incidence of disease in preterm infants found that presence of potential bacterial and viral pathogens

was not predictive of illness. Participants will consider evidence and gaps in knowledge of the diverse

and abundant microbiota of milk as predictors of protection for fresh breast milks.

Participants in the SRA symposium will discuss what is known about the healthy human milk

microbiome, research gaps, researchable questions, and potential improvements for developing

evidence-based policies and risk communications for milks. Panelists and participants will consider: 1)

evidence on risks and benefits of fresh unprocessed or Holder pasteurized human milk on preterm

infants (NICU and others); 2) researchable questions to reduce uncertainties for risks and benefits and

strengthen the scientific basis for evidence-based decisions for breast milk banks; 3) evidence for other

SRA Round Table Panel Symposium: Joint Regional Organization Project on Microbiota of Milks

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milks (bovine); and 4) how stakeholders can contribute to assessing and balancing risks and benefits for

the microbiota of milks in the 21st century.

The SRA project will continue in 2018 with a 2.5-day SRA workshop to exercise analytic-deliberative

process considering extensive bodies of evidence for both human and bovine milks. International experts

from diverse disciplines (predictive microbiology, microbial ecology of milks, immunology, neonatology,

food safety), as well as microbial risk assessors, risk communicators, and risk managers, will present and

participate in interdisciplinary exercises with stakeholders to ‘let the data speak’. As demonstrated for

other controversial societal issues, the vision and goals of SRA (http://www.sra.org/about-society-risk-

analysis) align well with providing a respectful meeting place to air competing views of the bodies of

evidence supporting divergent positions about the safety of milks around the globe. The deliberations of

participants may identify points of convergence, researchable questions, and communication and

management options to balance risks and benefits and promote evidence-based decision making

informed by advances in understanding of microbiota compositions and functions. Presenters will

contribute manuscripts from the workshop exercises in a special collection for submission to the SRA

journal Risk Analysis in 2019.

For updates and further information, check Upstate NY SRA website (http://sra.org/upstateny) or email

inquiries to peg@colemanscientific.org.

Questions for the Panel:

1. What changes are induced in breast milk by Holder pasteurization? What uncertainties remain in our

knowledge of the effects of pasteurization on breast milk with regard to infant health and disease?

2. What are the risks and benefits of pasteurizing donor breast milk for infants (NICU and others)? How

does pasteurization affect the development of infant microbiota, immune, and gastrointestinal

systems? Transmission of and resistance to disease? The ability of infants to grow and thrive?

3. Why did human milk banks in Australia, New Zealand, and US decide to require pasteurization of

donor breast milk? Why did human milk banks in Norway decide not to require pasteurization of

donor breast milk? What trends are observed for health and disease under the different risk

management strategies?

4. What researchable questions might reduce uncertainties for risks and benefits and strengthen the

scientific basis for evidence-based decision making?

5. Next topic (2018 workshop): What is evidence on risks and benefits of other milks (e.g., bovine)? How

can stakeholders contribute to assessing and balancing risks and benefits for the microbiota of milks

in the 21st century?

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2. American Academy of Pediatrics (AAP), Committee on Nutrition, AAP Section on Breastfeeding, AAP Committee on Fetus and

Newborn. 2017. Donor Human Milk for the High-Risk Infant: Preparation, Safety, and Usage Options in the United States. Pediatrics

139(1):e20163440.

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